Background and Objectives: The objective of the study was to formulate and evaluate fast
disintegrating oral film of zolmitriptan.
Method: The film was prepared by solvent casting method using different polymers like Lycoat
RS720, PVP K-30, and HPC in combination with other excipients. All prepared formulations were
evaluated for physico-mechanical properties. Films were also evaluated for % moisture uptake, % moisture
content, in vitro
drug release studies and in vitro
disintegration time. The optimized formulation
(L1) was subjected to stability study as per the ICH guidelines at 40 ± 0.5°C/75 ± 5% RH for six
months. in vivo
studies were conducted on Wistar albino rats and concentration of drug in blood was
analysed by HPLC. Various pharmacokinetic parameters for optimized formulation were determined
and compared with reference (drug sol.).
Results: On the basis of results of physico-mechanical properties and other parameters like in vitro disintegration
time, the formulation L1 was selected as optimized formulation. The optimized formulation
was found to be stable under the specified storage condition. The value of AUC0–t (ng h/ml), AUC0–∞
(ng h/ml) Cmax (ng/ml), Tmax (h), Ke (h -1
), and t1/2
(h) of the optimized film formulation was found to
be 727.72 ± 23.63, 777.17 ± 31.82, 353.67 ± 9.98, 0.5, 0.253 ± 0.023, and 2.74 ± 0.31 respectively, for
the drug sol 559.71 ± 27.52, 585.18 ± 36.53, 280.87 ± 28.98, 0.5, 0.295 ± 0.032, and 2.34 ± 0.35,
respectively. Relative bioavailability of optimized film formulation (L1) was 1.33 time than that of drug
sol. in vitro
relationship between percentage drug absorbed and percentage drug released was
also established. A moderate type of relationship (R2=0.897) was observed between percentage drug
absorbed and percentage drug released.
Conclusion: The results of present study showed that fast disintegrating oral film approach is suitable
for the delivery of zolmitriptan. This formulation not only increase the bioavailability of drug but also
produce the quick action for the migraine patients.